Compliance Update Alert: MDR introduces 22 new rules to classify medical devices
A comprehensive guide to medical device classification EU was published on October 20, 2021 by The Medical Device Coordination Group (MDCG). MDCG guidelines are detailed in a 57-page document, detailing how medical devices are classified, and providing rules to help in this process. The document also discusses how the classification affects pre- and post-market regulatory […]